Drug facts
MoleculeDuloxetine
Generics already compete: 16 makers on the market. 52 A-rated products from 16 makers substitute at the counter.
Cymbalta was first approved by the FDA on 08/03/2004 under NDA 021427; the application holder is Eli Lilly and Co. The Orange Book lists NDA 021427 as discontinued.
The latest NADAC for DULOXETINE HCL DR 60 MG CAP is $0.14 per unit (as of 10/28/2026).
Holder Eli Lilly and CoApplication NDA 021427Approved 08/03/2004
01Patents and exclusivity
When competition can legally begin. A generic can launch once both exclusivity and the last listed patent expire, unless a court or settlement says otherwise.
- Latest patent
- No Cymbalta patent listed in the Orange Book Orange Book
- Later patents, other products
- Duloxetine Hydrochloride (NDA 219131) 01/13/2046; Drizalma Sprinkle 04/13/2037 Orange Book
02Competition
- Generics
- 16 generic makers Orange Book
- First generic approved
- 12/11/2013 Orange Book
Every listingEach listing and maker behind the generics count.
Price erosionHow NADAC moves as generics enter.
PrescribersWho prescribes it, from Medicare data.
Available in the full Duloxetine profile.See what is included
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
- NADAC
- $0.14 per unitDULOXETINE HCL DR 60 MG CAP, mid-priced of 6 strengths, as of 10/28/2026 CMS NADAC
- Latest recall
- 06/22/2026Class II, Duloxetine D/R, Direct Rx FDA enforcement
04Product
- Application holder
- Eli Lilly and Co Orange Book
- Application
- NDA 021427 Orange Book
- First approved
- 08/03/2004 Orange Book
- Dosage forms
- capsule, delayed rel pellets
- Routes
- oral
- Other brand names
- Drizalma Sprinkle
- Status
- NDA 021427 discontinued Orange Book
Sources: FDA Orange Book, FDA Purple Book, FDA drug shortages, FDA enforcement reports and CMS NADAC, read through QOPE. Not medical or legal advice.